BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7262782 · Received February 12, 2018

    Report

    Report Number
    2951250-2018-00608
    Event Type
    Injury
    Date Received
    February 12, 2018
    Report Date
    December 12, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PUNCTURED A HOLE IN LEFT TUBE DURING INSERTION') AND LOSS OF CONSCIOUSNESS ('BLACKED OUT DURING CONFIRMATION HSG') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: INTENTIONAL DEVICE MISUSE "SHE HAD NOVASURE DONE AT THE SAME TIME AS ESSURE PLACEMENT" ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("HAD ESSURE INSERTED AND IT WAS VERY PAINFUL"), DEVICE INSERTION FAILED ("ONLY ABLE TO INSERT IN THE RIGHT TUBE") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION") AND UNDERWENT EYEGLASSES THERAPY ("MY GLASSES PRESCRIPTION HAS CHANGED 4 TIME"). THE PATIENT WAS TREATED WITH SURGERY. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, LOSS OF CONSCIOUSNESS, PROCEDURAL PAIN, DEVICE INSERTION FAILED, COMPLICATION OF DEVICE INSERTION AND EYEGLASSES THERAPY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE INSERTION FAILED, FALLOPIAN TUBE PERFORATION, LOSS OF CONSCIOUSNESS, PROCEDURAL PAIN AND COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED EYEGLASSES THERAPY TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA:EYEGLASSES THERAPY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-DEC-2019: SOCIAL MEDIA RECEIVED. REPORTER'S INFORMATION WAS ADDED. ADDED EVENT MY GLASSES PRESCRIPTION HAS CHANGES 4 TIMES. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PUNCTURED A HOLE IN LEFT TUBE DURING INSERTION") AND LOSS OF CONSCIOUSNESS ("BLACKED OUT DURING CONFIRMATION HSG") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: INTENTIONAL DEVICE MISUSE "SHE HAD NOVASURE DONE AT THE SAME TIME AS ESSURE PLACEMENT" ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("HAD ESSURE INSERTED AND IT WAS VERY PAINFUL"), THE FIRST EPISODE OF COMPLICATION OF DEVICE INSERTION ("ONLY ABLE TO INSERT IN THE RIGHT TUBE") AND THE SECOND EPISODE OF COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, LOSS OF CONSCIOUSNESS, PROCEDURAL PAIN AND THE LAST EPISODE OF COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR FALLOPIAN TUBE PERFORATION, LOSS OF CONSCIOUSNESS, PROCEDURAL PAIN, THE FIRST EPISODE OF COMPLICATION OF DEVICE INSERTION AND THE SECOND EPISODE OF COMPLICATION OF DEVICE INSERTION WITH ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONCES WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2018: CASE CLASSIFICATION UPDATED TO POTENTIAL LEGAL CASE AND SURGERY WAS TICKED TO FALLOPIAN TUBE PERFORATION CASE CATEGORY UPDATED TO INCIDENT. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107533 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R